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[Posted 3/1/2012]ISSUE:FDA notified healthcare professionals of updates to the prescribing information concerning interactions between protease inhibitors and certain statin drugs. Protease inhibitors and statins taken together may raise the blood levels of statins and increase the risk for muscle injury (myopathy). The most serious form of myopathy, called rhabdomyolysis, can damage the kidneys and lead to kidney failure, which can be fatal.
BACKGROUND:Statins are a class of prescription drugs used together with diet and exercise to reduce blood levels of low-density lipoprotein (LDL) cholesterol (''bad cholesterol''). HIV protease inhibitors are a class of prescription anti-viral drugs used to treat HIV. HCV protease inhibitors are a class of prescription anti-viral drugs used to treat hepatitis C infection.
RECOMMENDATION:Healthcare professionals should follow the recommendations in the prescribing information (drug labels) when prescribing HIV or HCV protease inhibitors with statins. See the FDA Drug Safety Communication for additional information, including a data summary. For more information visit the FDA website at: Web Siteand Web Site.
WHY is this medicine prescribed?
Nelfinavir is used in combination with other medications to treat human immunodeficiency virus infection (HIV) in patients with or without acquired immunodeficiency syndrome (AIDS). Nelfinavir is one of a class of medications called protease inhibitors. It works by slowing the spread of HIV infection in the body. Nelfinavir does not cure HIV and may not prevent you from developing HIV-related illnesses, including other infections. Nelfinavir does not prevent the spread of HIV to other people.
HOW should this medicine be used?
Nelfinavir comes as a tablet and a powder to take by mouth. It is usually taken two to three times a day with food. Take nelfinavir at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take nelfinavir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
If you are unable to swallow the tablet, you may put it in a glass and dissolve it in a small amount of water. Mix the liquid well, and drink it immediately. Rinse the glass with more water and swallow the entire mixture to make sure you have taken all of the medication.
Nelfinavir oral powder may be added to water, milk, formula, soy milk, or dietary supplements. Mix well, and drink all of the liquid right away in order to take the full dose. Your prescription label tells you how many scoops of nelfinavir powder to add to the liquid. If the mixture is not taken immediately it must be stored in the refrigerator and taken within 6 hours. Do not mix nelfinavir oral powder with acidic food or juice (orange juice, apple juice, or apple sauce). Do not mix nelfinavir with water in the original container.
Nelfinavir controls HIV infection but does not cure it. Continue to take nelfinavir even if you feel well. Do not stop taking nelfinavir without talking to your doctor. If you stop taking nelfinavir or skip doses, your infection may get worse or become resistant to medications.
Are there OTHER USES for this medicine?
This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking nelfinavir,
- tell your doctor and pharmacist if you are allergic to nelfinavir or any other medications.
- do not take nelfinavir if you are taking amiodarone (Cordarone, Pacerone); ergot-type medications such as bromocriptine (Parlodel), cabergoline (Dostinex), dihydroergotamine (D.H.E. 45, Migranal), ergoloid mesylates (Gerimal, Hydergine), ergotamine (Cafergot, Ergomar, in Migergot, others), and methylergonovine (Methergine); midazolam (Versed); pimozide (Orap), quinidine (Quinaglute, Quinalan, Quinidex, others); and triazolam (Halcion).
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following:, azithromycin (Azasite, Zithromax, Zmax); certain calcium-channel blocking medications such as amlodipine (Norvasc, in Caduet, Lotrel), felodipine (Plendil, in Lexxel), isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat, Nifedical, Procardia), nimodipine (Nimotop), and nisoldipine (Sular); carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, others); cholesterol-lowering medications (statins) such as atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol), and simvastatin (Zocor); cisapride (Propulsid, not available in the US); delavirdine (Rescriptor); disopyramide (Norpace);dofetilide (Tikosyn); erythromycin (E.E.S., E-Mycin, Erythrocin); fluticasone (Flonase, Flovent); indinavir (Crixivan); medications that suppress the immune system such as azathioprine (Imuran), cyclosporine (Neoral, Sandimmune), methotrexate (Rheumatrex), sirolimus (Rapamune), and tacrolimus (Prograf); methadone (Dolophine, Methadose); moxifloxacin (Avelox); nevirapine (Viramune); phenobarbital; phenytoin (Dilantin, Phenytek, others); procainamide (Procanbid, Pronestyl); proton-pump inhibitors such as esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), and rabeprazole (AcipHex); rifabutin (Mycobutin); rifampin (Rifadin); ritonavir (Norvir in Kaletra); saquinavir (Invirase); sildenafil (Revatio, Viagra); sotalol (Betapace); sparfloxacin (Zagam); tadalafil (Cialis); thioridazine (Mellaril); trazodone; and vardenafil (Levitra).
- tell your doctor and pharmacist what herbal products you are taking, especially St. John's wort.
- if you are taking didanosine (Videx), take it 1 hour before or more than 2 hours after nelfinavir.
- tell your doctor if you are taking birth control pills. Nelfinavir can decrease the effectiveness of oral contraceptives. You should use another method of birth control while taking this medication. Talk to your doctor about birth control while taking nelfinavir.
- tell your doctor if you have or have ever had diabetes; hemophilia (a group of inherited bleeding disorders in which the ability of blood to clot is not normal)or liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking nelfinavir, call your doctor. You should not breast-feed if you have HIV infection and are taking nelfinavir.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking nelfinavir.
- you should be aware that your body fat may increase or move to different areas of your body, such as your upper back, neck ('buffalo hump'), breasts, and around your stomach. You may notice a loss of body fat from your face, legs, and arms.
- if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent mental retardation), you should know that nelfinavir oral powder is sweetened with aspartame that forms phenylalanine.
What should I do IF I FORGET to take a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What SIDE EFFECTS can this medicine cause?
Nelfinavir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- stomach pain
- loss of appetite
Call your doctor immediately if you have any of the following symptoms of hyperglycemia (high blood sugar):
- extreme thirst
- frequent urination
- extreme hunger
- blurred vision
If high blood sugar is not treated, a serious, life-threatening condition called diabetic ketoacidosis could develop. Get medical care immediately if you have any of these symptoms:
- very dry mouth
- shortness of breath
- breath that smells fruity
- decreased consciousness
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
- difficulty breathing or swallowing
Nelfinavir contains a chemical found to cause cancer in laboratory animals. The Food and Drug Administration (FDA) has asked the manufacturer to make changes in the way nelfinavir is made to decrease the amount of this chemical in nelfinavir products. The risk to humans is unknown, but may be higher in children and pregnant women. Talk to your doctor about the risks of taking nelfinavir.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at Web Site] or by phone [1-800-332-1088].
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). After nelfinavir powder has been added to liquid, the mixture may be kept at room temperature for up to 6 hours. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
What should I do in case of OVERDOSE?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What OTHER INFORMATION should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to nelfinavir.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
Keep a supply of nelfinavir on hand. Do not wait until you run out of medication to refill your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.
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